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| |  Older Cancer Patients in the Community Setting Can Benefit From Pegfilgrastim By Cameron E. Johnston ORLANDO, FL -- May 20, 2005 -- Results of a large prospective, open-label trial of elderly patients with non-Hodgkin's lymphoma (NHL), lung, breast, or ovarian cancer show that this population can be safely treated with pegfilgrastim in the community setting. According to the researchers, patients achieved a greater benefit when the growth factor was started beginning with the first cycle of chemotherapy than when the dosing was started at the first sign of neutropenia. In a poster presentation here May 16th at the American Society of Clinical Oncology Annual Meeting (ASCO), Lodovico Balducci, MD, medical oncologist and program leader, Senior Adult Oncology Department, H. Lee Moffitt Cancer Center, Tampa, Florida, discussed the results of the study on behalf of the Geriatric Oncology Consortium. The consortium consists of multiple community oncology practices and conducts research and educational programs specifically targeted for the elderly cancer population. It includes more than 150 oncology practices in the US. The 2 treatment arms were as follows: group 1, 343 patients who were randomized to receive pegfilgrastim with every cycle of chemotherapy; group 2, 343 randomized to receive pegfilgrastim in cycles 2 through 6 at the discretion of the treating physician. In group 1, 45% had non-small-cell lung cancer (NSCLC), 11% had small-cell lung cancer (SCLC), 27% had breast cancer, and 17% had ovarian cancer. In group 2, 39% had NSCLC, 17% had SCLC, 27% had breast cancer, and 18% had ovarian cancer. Planned chemotherapy regimens varied between the groups. Patients in group 1 were treated with carboplatin/paclitaxel (37%), carboplatin/etoposide (13%), doxorubicin/cyclophosphamide (15%), and carboplatin/docetaxel (13%). Patients in group 2 were treated with carboplatin/paclitaxel (35%), carboplatin/etoposide (18%), doxorubicin/cyclophosphamide (15%), and carboplatin/docetaxel (10%). The incidences of neutropenia and febrile neutropenia were both significantly higher in patients who did not receive pegfilgrastim in cycle 1. Sixty-eight percent of group 2 developed neutropenia after cycle 1, and 80% developed it over the next 5 cycles, compared to 26% and 30% in group 1. Neutropenia in group 1 caused dose delays in 16% of patients, dose reductions in 7%, hospitalization in 5%, and anti-infective therapy in 12%. In group 2, the figures were 28%, 14%, 9%, and 29%. The rates of neutropenia were 19% in the group that received carboplatin/etoposide, 10% in those given doxorubicin/cyclophosphamide, and 14% in those given carboplatin/docetaxel. Among group 1 patients, 2% developed neutropenia regardless of the chemotherapy regimen they were receiving. According to Dr. Balducci, the study demonstrates that pegfilgrastim can be delivered safely to elderly patients in the community setting and it is not necessary for the patient to attend a dedicated cancer centre to receive the treatment. Perhaps more importantly, he said, use of this agent starting in the first cycle of chemotherapy has a much greater benefit than administering it when the patient begins to show signs of developing neutropenia. The study was funded by Amgen Inc.
[Presentation title: A Large Study of the Older Cancer Patient in the Community Setting: Initial Report of a Randomized Controlled Trial Using Pegfilgrastim to Reduce Neutropenic Complications. Abstract 8111]
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